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NCT01698801 · FLOW

Participant flow

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-11-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
    id
    FG000
    title
    Lenalidomide Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. comment
        Completed includes participants who continued to receive study medication and treatment is ongoing.
        group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    milestones
    1. achievements
      1. comment
        11 participants did not complete the study and moved into the follow up phase lasting up to 5 years.
        group Id
        FG000
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. comment
        Completed includes participants who remain in follow-up for up to 5 years from start of treatment
        group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Follow Up Phase
pre Assignment Details
This is an ongoing open-label, single arm, 5 year study consisting of a 28-day screening period followed by a treatment period where participants receive lenalidomide and dexamethasone until their disease progresses or the lenalidomide is discontinued for any reason. This report includes data up to the cut-off of 15 July 2014.
Complete source fields
groups
  1. description
    Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
    id
    FG000
    title
    Lenalidomide Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. comment
        Completed includes participants who continued to receive study medication and treatment is ongoing.
        group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    milestones
    1. achievements
      1. comment
        11 participants did not complete the study and moved into the follow up phase lasting up to 5 years.
        group Id
        FG000
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. comment
        Completed includes participants who remain in follow-up for up to 5 years from start of treatment
        group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Follow Up Phase
pre Assignment Details
This is an ongoing open-label, single arm, 5 year study consisting of a 28-day screening period followed by a treatment period where participants receive lenalidomide and dexamethasone until their disease progresses or the lenalidomide is discontinued for any reason. This report includes data up to the cut-off of 15 July 2014.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice